Answering FSMA's Sanitary Transportation Rule's Biggest Questions

By Sam Lewis

Be sure to view the entire web chat or read Part One of this series

On Tuesday, March 14, GMA and ATA partnered with Food Online for a live web chat, Food For Thought: FSMA’s Sanitary Transportation Rule. In this 45-minute live Q&A, Jon Samson, Executive Director of AFTC at ATA and Samantha Cooper, manager of Food Safety and Quality Assurance at GMA joined Food Online’s editor, Sam Lewis, to answer the food industry’s questions on the topic.

Sam: Is there anything pertinent to know as far, as ready-to-eat fresh cut products, regarding FSMA’s Sanitary Transportation Rule? Would it have to do with if that product is touching a trailer or if it's boxed? Samantha, could you address that?

Samantha: If it's ready-to-eat fresh cut, I don't think it would be in an open container. Again, if it's completely enclosed and doesn't require temperature control, then it's excluded. If you're using maybe an open plastic tote or a container, then it would be subject to the rule. You have to make sure it's adequately maintained, cleanable, constructed of the appropriate materials.

Like Jon and I keep going back to, this rule does provide a lot of flexibility. The different key requirements, or the procedures that you would put in place for this rule, would be dependent upon that food that you're transporting. You're going to have a different kind of set up for a fresh-cut product than maybe you'd have for a pet food container.

Jon: To go a little bit outside of the fresh-cut product, there is a change to the definition of what products are exempted from the rule. Initially, it was fully enclosed, shelf-stable products that were exempted because the final focus from the FDA really is on simply food safety. They generalized that exemption to fully-enclosed food products that are not temperature controlled for safety. That ended up exempting all frozen food products.

The agency’s understanding or thinking behind it is if you pull up with a trailer full of frozen products, and it's no longer frozen, then it's going to be rejected on quality before they're ever going to even test it for safety. They ended up, as long as the product's frozen and it's completely enclosed, then it's completely exempted from the rule.

Now, and this probably too much information for the question, but even though it's exempted from the rule, a lot of these shipping contracts that we're seeing are requiring the same requirements anyway because they want to see that sanitization. They want to see the temperatures. They want to see other things. The FDA is not going to come knocking and audit frozen food products, but we're seeing those take place as far as industry goes and shipping contracts.

Sam: Related to that, you both keep mentioning the flexibility of this rule. Sort of to the next level of this, a question has come in and it says: given the high level of flexibility and ambiguity within the Sanitary Transportation Rule, how will enforcement be handled, and is the FDA the enforcement entity?

Samantha: It's actually going to be a combination of enforcement for this rule. The FDA will take part, as well as the Department of Transportation. It's going to kind of be a shared duty to check up on the enforcement of this rule. Jon, I don't know if you have more to add to that.

Jon: We've actually started to see state-related legislation that is asking the State Department of Agriculture to actually have enforcement over FSMA in a lot of the states. The reason they're requesting that is you've got the Food Safety Inspection Service (FSIS), which already has enforcement over eggs, meat products, as well as poultry. As Samantha said, all three are working together, but they also want to have the states to have some say. They want to have some actual agency to go to and say, "Are you enforcing this?" Right now, what we're starting to see in a lot of the states is that agency is going to be the Department of Agriculture.

I'm sure different states will do different things, but it makes a lot of sense to a lot of states because of the current agriculture enforcement. That really goes back to when they passed the original food safety transportation law in 1990. They gave it to the Department of Transportation, who knew nothing about food. Then in 2005, when they passed the sanitary transportation law, they gave it to the FDA. As we really came to understand, especially at the beginning, they didn't know that much about transportation. They're really trying to figure out a way where the enforcement has already had experience of actually enforcing food products. It's going to be a group effort at the end of the day.

Sam: It seems that there's definitely less prescription and more flexibility, as everyone is mentioning. It's certainly lending its hand to some serious questions.

Jon, I'm going to switch to something that might be very specific for you. It has to do with third-party transportation. This question came in: We do not have our own transportation, we hire transportation. Currently, we do truck inspections before loading and unloading trucks to make sure they are clean and refrigeration is working. We seal the trucks with our own seals for security. What should we be asking the transporters to provider to ensure that they are following FSMA's Sanitary Transportation Rule?

Jon: If you don't have your own carrier company and you're arranging for the transportation, then you'll fall underneath the heading of a shipper. Given that example, and we've had that example — “the drop-and-hitch” where the trailer's already loaded and the carrier, off he goes — it's really going to be up to whatever contract agreement that you have with the carrier to what you think he needs to be able to carry out.

If you think that the product needs to be constantly monitored every 15 minutes, then that needs to be laid out in the contract. If you believe that you're required to make sure that equipment's running properly and that everything is cleaned, sanitized to your liking, that should be too.

Additionally, especially if you're the one loading the trailer, then that carrier doesn't have quite the liability that he did before as far as meeting some of these requirement. If you don't want to place additional requirements on the carrier, then you need to do so within that contract. That's the important distinction here. Even though the shipper is the major liability party here, they do have the flexibility within the rule to ship that liability to the carrier or other parties that fall under the rule, and then that liability is now shared. I think that's important, but it's really going to be what specifics you want the carrier to pay attention to when he's hauling the product.

Samantha: I agree with Jon. I think the other part mentioned, security of the trailer, that is kind of out of scope of the rule, at least for the Sanitary Transport Rule. There's no requirement for having the safety seals.

Sam: We're going to head back to compliance. We'd had a question come in for Samantha. What records are required under FSMA’s Sanitary Transportation Rule for compliance?

Samantha: It's going to be different for everyone, depending on which definition you fall under. It's going to differ for if you're the shipper or if you're the receiver or the carrier. In general, records have to be retained for 12 months after their use. In the preamble of the rule — If you haven't had the time yet to go online and download the rule, the preamble is a very important part of the regulation — it has a lot of additional information in there. I do a lot of different teaching classes, and sometimes no one raises their hand that they actually read the preamble. Read the preamble if you haven't read it yet.

In general, a shipper would have records that demonstrate that they provide specifications for the vehicle. The shipper would create that — going back to the previous question that Jon had answered — documentation for what they're requiring of the carrier if they want to transfer the responsibility to the carrier. They would have written procedures, similar to SOPs, and this would ensure that the vehicles and the equipment are of the appropriate condition.

Another part of the record they would have, so for food transported in bulk, and this has changed in the preamble, there is no requirement. Going back, in the proposed rule, there was a proposal to have the previous three bulk shipments communicated. There's no longer that requirement. If you wanted to, you could have a written procedure to say that you wanted to know what the previous load was for that bulk container. That would ensure that the food's safe, so nothing was contaminated inside of it.

Then if you have food that requires temperature control, you would have that record documenting: what was that temperature? FDA doesn't envision you to have rooms filled with records for this rule. A lot of the records are going to pertain to the procedure that has to be followed.

Jon: I was all ready to go with my answer, and then, with your last sentence, you stole all of my good stuff. As Samantha said, there were changes made from the proposed rule to the final rule, and they were big. Because even though they didn't want the carrier or the shipper or anybody to have a room full of records, the way that things were written, there was a potential where they were going to have to have records from every single shipment that was done over the past 12 years. As Samantha very correctly pointed out, they really paired that back to where the records the FDA wants to see is the process and the procedures that are in place. They want to see what you cleaning and sanitization process is. They don't want to see when trailers were cleaned and how often they were cleaned; they just want to see that process that was in place. That was another big change that was made from the proposed to the final rule.

Samantha: Another question I get a lot, I don't know if it was asked yet, but it asks where the records should be kept. The FDA does allow for electronic records, but there is an exception. The carriers' written procedures for the cleaning, sanitizing, inspection of vehicles, and transportation equipment have to remain on site. That has to be physically on site, but other records can be kept online electronically.

Sam: Great insight. Thank you, both. . I'm going to come to Samantha for another compliance question. Can you talk about how the Sanitary Transportation Rule affects imports, even Canada? Food comes in across the border from sea. It comes over from rail car. It comes in through trucks. Can you sort of give a broad view of how the rule affects imports and exports, including Canada, via all the methods of transportation?

Samantha: Imports will be important. Again, if you're not aware, there is another rule the FDA has for us called the Foreign Supplier Verification Program (FSVP). If you are in the business of importing, you should also take a look at that rule. Speaking back to the Sanitary Transportation Rule, the rule only covers shipments by railcar or motor vehicle. Any shipments by air or ship are actually out of scope of this rule, and then this rule only applies to those shipments within the U.S.

It may be a little bit difficult, and I know for me when I first read the rule, it was hard to wrap my head around. You could have a shipment, but maybe you have a foreign shipper overseas, and the rule wouldn't come into effect until it was actually on the first leg of the journey in the U.S. It could come over by air, maybe it then goes on a boat, and then it finally gets into a railcar. The rule would kind of start covering it at that point. As far as Canada laws, I'm not really familiar. I'm not sure what CFIA has covered for shipments in Canada. I can't expand on that.

Jon: I haven't seen the details of them, but Canada was going through very similar food safety rules. They were kind of waiting on the U.S to wrap them up. I would believe, or I would think that the changes in their new requirements, are probably somewhat similar to what the U.S. has. They wanted to do that to make it a little bit easier for those imported and exported products, which, again, another big change in the rule.

If you're importing, if Mexico's importing produce and it's being trans-shipped through the U.S. to Canada, then it doesn't fall under the rule. However, if you are manufacturing a product in Nebraska and you are going to send that to California to be exported, then it actually, even though it's not being consumed in the U.S., that product still falls underneath the Sanitary Transportation Rule until it gets loaded onto the ship or onto whatever form of transportation when it's leaving the U.S. I think those are two important distinctions.

In Part Three of this series, Jon and Samantha will continue to answer questions from the web chat’s live audience. Stay tuned.